https://orcid.org/0000-0002-7019-9727
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Abstract
Purpose
Postoperative pain relief after laparoscopic appendicectomy is a key determinant of early rehabilitation in children. Recent guidelines recommend performing either a transversus abdominis plane (TAP) block or local anesthesia (LA) wound infiltration as part of multimodal postoperative analgesia after appendectomy. To date, the clinical effectiveness of TAP block versus LA wound infiltration has never been compared. The hypothesis of this study is that the TAP block may provide a greater opioid-sparing effect after laparoscopic appendicectomy in children than LA wound infiltration.
Study Design and Methods
We designed a multicenter double-blind randomized controlled phase III trial and aim to include 110 children who undergo laparoscopic appendicectomy. Children are randomized to receive either TAP block (TAP group) or LA wound infiltration (infiltration group). Multimodal analgesia is standardized in the two groups using the same protocol, which includes the stepwise prescription of paracetamol, phloroglucinol, ketoprofene, and nalbuphine according to the hetero-evaluation of pain performed by the nurses who were blinded to the treatment allocated using the validated FLACC scale. The primary outcome is the total dose of nalbuphine administered within 24 hours after surgery.
Discussion
No study has specifically compared the clinical effectiveness of TAP block versus LA wound infiltration for postoperative pain relief after laparoscopic appendectomy in children. This paper describes the protocol for a randomized trial that addresses this issue. The results of this trial will be useful for editing guidelines with a higher level of evidence on this topic.
Planning and Dissemination
Inclusions started on July 30, 2021. The initial planned duration of the trial was two years. No amendments were made to the study protocols. The University Hospital of Besancon (CHU Besancon, Besancon, France) is a trial sponsor and holder of all the data and publication rights. The results of this study will be submitted for publication in a peer-reviewed international medical journal and presented in an abstract form at national and international conferences.
Ethics Approval and Registration
This study was approved by the French Ethics Committee (Comité de Protection des Personnes Ile de France IV, Dr. Shahnaz Klouche, N°2021/15, March 24, 2021). The PABLO study was registered with ClinicalTrials.gov (Identifier: NCT04969133; principal investigator: Dr. Amélie Jurine, M.D., date of registration: July 20, 2021). This study is conducted in accordance with GCP-ICH-6 in two university-affiliated hospitals (CHU de Besancon, Besancon, France and CHU de Dijon, Dijon, France) and in accordance with the Declaration of Helsinki. Eligible patients are screened in the pediatric emergency department or pediatric surgery department during the preoperative anesthetic assessment, within hours preceding the surgical procedure. Holders of parental authority and eligible children receive all information related to the study. Informed consent is obtained by investigators from both eligible children (oral informed consent if age <6 years; written informed consent if age >6 years) and at least one holder of parental authority before inclusion in the study, according to French law.Citation9
Acknowledgments
This work is funded by CHU Besançon, Besançon, France, and Région Bourgogne Franche-Comté, France.
Disclosure
Dr Maxime Nguyen reports grants and/or personal fees from Baxter, Pfizer, Fresenius, during the conduct of the study; personal fees from Pfizer, personal fees from Fresenius; grants from Baxter, outside the submitted work. The authors report no other conflicts of interest in this work.